Label: ANTI ITCH BALM  - peppermint oil ointment 

  • Label RSS
  • NDC Code(s): 57285-100-01, 57285-100-02
  • Packager: US ORGANIC GROUP CORP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 03/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Peppermint Oil* ---------- 0.34%

    *=Certified Organic Ingredient


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  • PURPOSE

    Anti-Itch

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  • INDICATIONS & USAGE

    Temporarily relieves itching associated with Insect bites, Eczema, Minor burn, Sunburn, Minor skin irritations, minor cuts, scrapes, atopic dermatitis.

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  • ASK DOCTOR

    Ask a doctor if condition worsen

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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  • WARNINGS

    - For external use only

    - Do not use in or near the eyes

    - Keep out of reach of children

    - Ask a doctor if condition worsen

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  • INSTRUCTIONS FOR USE

    - Apply affected area and rub rapidly for 10 seconds

    - Adults and children 2 years of age and older

    - Children under 2 years of age: ask a doctor

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  • DOSAGE & ADMINISTRATION

    Apply affected area and rub rapidly for 10 seconds.

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  • INACTIVE INGREDIENT

    Simmondsiachinensis (Organic Jojoba oil)*,Helianthus annuus (Organic Sunflower oil)*,Butyrospermumparkii (Organic Shea butter)*,Cera alba (Organic Bees wax)*,Calophylluminophyllum (Organic Tamanu oil)*,Oenotherabiennis (Organic Evening primerose oil)*,Rosemarinusoficinalis (Organic Rosemary) extract*,Vitamin E Oil,Lavandulaangustifolia (Organic Lavender essential oil)*,Melaleucaalternifolia (Organic Tea tree essential oil)*,Matricariarecutita (Organic Chamomile blue essential oil)*,Anthemisnobilis (Organic Chamomile roman essential oil)*,Boswelliacarterii (Organic Frankincense essential oil)*,Achilleamillefolium (Organic Yarrow blue essential oil)*
    *= Certified Organic Ingredient

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  • INGREDIENTS AND APPEARANCE
    ANTI ITCH BALM  
    peppermint oil ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:57285-100
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Peppermint Oil (Peppermint) Peppermint Oil 0.0952 g  in 28 g
    Inactive Ingredients
    Ingredient Name Strength
    JOJOBA OIL  
    SUNFLOWER OIL  
    SHEA BUTTER  
    YELLOW WAX  
    TAMANU OIL  
    EVENING PRIMROSE OIL  
    ROSEMARY OIL  
    .ALPHA.-TOCOPHEROL  
    LAVENDER OIL  
    TEA TREE OIL  
    CHAMOMILE FLOWER OIL  
    CHAMAEMELUM NOBILE FLOWER OIL  
    FRANKINCENSE OIL  
    ACHILLEA MILLEFOLIUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57285-100-02 1 in 1 CARTON
    1 NDC:57285-100-01 28 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/29/2013
    Labeler - US ORGANIC GROUP CORP (078748578)
    Registrant - LEORARD MOON (078748578)
    Establishment
    Name Address ID/FEI Business Operations
    US ORGANIC GROUP CORP 078748578 manufacture(57285-100)
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